EP0551017A1 - Implantable infusion device - Google Patents
Implantable infusion device Download PDFInfo
- Publication number
- EP0551017A1 EP0551017A1 EP92311887A EP92311887A EP0551017A1 EP 0551017 A1 EP0551017 A1 EP 0551017A1 EP 92311887 A EP92311887 A EP 92311887A EP 92311887 A EP92311887 A EP 92311887A EP 0551017 A1 EP0551017 A1 EP 0551017A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- needle
- plug
- filament
- implantable access
- ball
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 238000001802 infusion Methods 0.000 title claims abstract description 21
- 238000007789 sealing Methods 0.000 claims abstract description 48
- 239000000463 material Substances 0.000 claims abstract description 11
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- 239000002184 metal Substances 0.000 claims abstract description 8
- 239000013307 optical fiber Substances 0.000 claims abstract description 7
- 239000012530 fluid Substances 0.000 claims description 19
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- 238000002513 implantation Methods 0.000 description 1
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- 238000002347 injection Methods 0.000 description 1
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- 230000003993 interaction Effects 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
- A61M2039/0211—Subcutaneous access sites for injecting or removing fluids with multiple chambers in a single site
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/064—Slit-valve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/0653—Perforated disc
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0633—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof the seal being a passive seal made of a resilient material with or without an opening
- A61M2039/0666—Flap-valve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0686—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising more than one seal
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
- This invention is related to a patient access device and particularly to one which permits the introduction of an external filament such as a needle, external catheter, guide wire, or optical fiber transcutaneously.
- This invention relates to a device to enable multiple patient access procedures including infusing a therapeutic agent to a desired site within a patient, feeding a filament to a desired internal site, or withdrawing a fluid from a patient; and more particularly, to such a device which is implanted such that no portion is transcutaneous. Its access portion is subcutaneous but designed so as to facilitate repeated access by the percutaneous route.
- In current human and animal medical practice, there are numerous instances where therapeutic agents must be delivered to a specific organ or tissue within the body. An example is the infusion of chemotherapy into a central vein on a recurring basis over a lengthy treatment period for widespread sites of malignant tumor. Without an access device for intravenous drug infusion, multiple vein punctures over a lengthy period can result in progressive thrombosis, venous sclerosis, and destruction of small diameter peripheral vessels. In other cases, it may be desirable to infuse chemotherapy to a localized malignant tumor site. It may be difficult or impossible to deliver an agent specifically to such a site on a regular repetitive basis without surgically implanting an access system. Similarly, repeated arterial access is occasionally needed for injection of an X-ray dye or contrast agent into an artery for diagnostic purposes. In other situations, there is a need to remove a body fluid from a remote body site repetitively for analysis. Finally, sensing and physiological measuring devices incorporated into small diameter catheters and small diameter optical fibers are increasingly being utilized for monitoring body processes and could be more easily implemented through a properly designed access device with an adequate internal diameter.
- In prior medical practice, percutaneous catheters have been used to provide vascular or organ access for drug therapy or removing body fluids. Although such systems generally performed in a satisfactory manner, numerous problems were presented by such therapy approaches, including the substantial care requirements by patients, e.g. dressing changes with sterile techniques, a significant rate of infection of the catheter because of its transcutaneous position, and a high rate of venous thrombosis, particularly if the catheter was located within an extremity vein.
- Implantable infusion devices or "ports" have recently become available and are a significant advance over transcutaneous catheters. Presently available infusion ports have a number of common fundamental design features. The ports themselves comprise a housing which forms a reservoir which can be constructed from a variety of plastic or metal materials. A surface of the reservoir is enclosed by a high-density, self-sealing septum, typically made of silicone rubber. Connected to the port housing is an outflow catheter which communicates with a vein or other site within the patient where it is desired to infuse therapeutic agents. Implantation of such devices generally proceeds by making a small subcutaneous pocket in the patient under local anesthesia. The internal outflow catheter is tunnelled to the desired infusion site and is connected to the infusion port. When the physician desires to infuse or remove material through the port, a hypodermic needle is used which pierces the skin over the infusion port and is placed into the port.
- Although presently available implantable infusion ports generally operate in a satisfactory manner, they have a number of shortcomings. Since these devices rely on a compressed rubber septum for sealing, there are limitations in the diameter of needles which can be used to penetrate the septum, since large diameter needles can seriously damage the septum. These diameter limitations severely restrict the flow rate of fluids passing through the port. Moreover, the needles used must be of a special design which minimizes septum damage.
- For prolonged infusion using a conventional port, the infusion needle is taped to the patient's skin to hold it in position. Conventional ports do not allow the needle to penetrate deeply into the port; and consequently, a small displacement of the needle can cause it to be pulled from the port, allowing extravasation. In cases where locally toxic materials are being infused, extravasation of such materials can cause local tissue damage which can lead to a requirement for corrective surgery such as skin grafting or removal of tissue.
- Presently available implantable infusion devices must also have a significant size to provide an acceptable target surface area for the physician who must locate the port and penetrate the septum properly with a needle. The port housing becomes bulky as the septum size increases since structure is required to maintain the septum in compression to provide self-sealing after the needle is removed. Moreover, presently available infusion ports are difficult to clear if thrombosis occurs within them or in the implanted outflow catheter, since it is difficult if not impossible to feed a cleaning wire through the penetrating hypodermic needle in a manner which will clear the infusion device and the internal outflow catheter. Present infusion ports have a space which contains a retained fluid volume beneath the self-sealing septum which increases the volume of drug which must be administered to enable a desired quantity to reach the infusion site. This retained volume also poses problems when a physician desires to deliver different drugs to the same infusion site which are incompatible or rendered less effective when mixed. In addition, when it is desired to withdraw blood through the port, the retained volume of the prior art infusion ports is an area where blood clotting can occur, thus interfering with future access to the site. And finally, for present infusion ports, there is a risk that the physician attempting to pierce the port septum will not properly enter it, leading to the possibility of extravasation which can cause significant undesirable consequences as mentioned previously.
- In applicants' related patent application and issued patents, various approaches toward permitting transcutaneous access to implanted catheter are described. In accordance with those devices, multiple sealing members are used to provide an adequate fluid seal across the access device, both when an external filament is introduced into the device and after it is removed. The access ports in accordance with this invention achieve simplicity in construction and reduce the number of components necessary to provide the necessary fluid seal. In those applications where it is desired to access a port using a sharp needle, damage to elastomeric sealing elements can occur over repeated entries to the port in prior port designs. In accordance with this invention, the implanted port has an articulating valve mechanism in which the accessing needle (or other filament) contacts a hard material such as a metal to open the valve. Accordingly, a durable device is provided which is not damaged through long term use.
- The features of the present invention are primarily achieved through use of a valve assembly in which a sealing element is normally maintained in contact with a valve seat. When introducing an external filament, which may be a needle, catheter, wire, optical fiber etc., the filament engages the sealing element forcing it from engagement with the valve seat. Once fully inserted into the access device, features are provided to assure a fluid seal around the introduced filament.
- Additional benefits and advantages of the present invention will become apparent to those skilled in the art to which this invention relates from the subsequent description of the preferred embodiments and the appended claims, taken in conjunction with the accompanying drawings.
- Figure 1 is a cross-sectional view through an access port in accordance with a first embodiment of this invention shown in a normal condition in which an external filament is not present within the device.
- Figure 2 is a somewhat enlarged cross-sectional view of the access port of Figure 1 shown with an accessing needle penetrating the device.
- Figure 3 is an exploded pictorial view of the valve assembly of the port shown in Figures 1 and 2.
- Figure 4 is a cross-sectional view through an access port according to a second embodiment of this invention showing a valve assembly comprising metal seal elements affixed to a multileaf elastomeric valve disk.
- Figure 5 is a frontal view of the valve assembly of the port shown in Figure 4.
- Figure 6 is an exploded pictorial view of a valve assembly in accordance with a third embodiment of this invention incorporating a unitary seal member for sealing against the valve seat formed by a sealing disk.
- Figure 7 is a cross-sectional view of an access port incorporating the valve assembly shown in Figure 6 and further showing an accessing needle penetrating the device.
- Figure 8 is a cross-sectional view taken through an access port in accordance with a fourth embodiment of this invention shown with an accessing needle partially penetrating the device.
- Figure 9 is a cross-sectional view of the access port shown in Figure 8 but showing the accessing needle penetrating the valve assembly to permit access to an implanted catheter.
- An access device in accordance with this invention is shown in Figures 1 and 2, and is generally designated by reference number 10. As shown, access port 10 is similar to that described in applicant's issued patent numbers: 5,053,013 and 5,057,084, to which the present application is related. Access port 10 is designed to allow a sharp needle to access the device for purposes including infusing drugs or other fluids in the patient or withdrawing fluids from the patient. Access port 10 generally has
housing 12 which defines a generally funnelshaped entrance orifice 14.Entrance orifice 14 has a decreasing cross-sectional area which ends athousing passageway 16. The shape ofentrance orifice 14 serves to guide a needle intopassageway 16. To that end, the surface ofhousing 12 formingorifice 14 is a hardened material such as titanium which has been found to be acceptable for this application. -
Housing 12 together withoutlet plug 18 definevalve chamber 20 located betweenpassageways catheter connector tube 24 ofoutlet plug 18 is bent to provide a positive means for preventing an introduced needle from passing entirely through the device and potentially damaging a soft elastomeric implantedcatheter 26.Connector tube 24 does, however, permit more flexible filaments such as a catheter, guide wire or optical fiber to pass into implantedcatheter 26. Mountingpad 28 enables the device to be conveniently mounted to subcutaneous support tissue preferably using sutures, staples, or other fasteners. -
Valve assembly 34 is disposed withinvalve chamber 20 and is best described with reference to Figure 3.Valve disk 36 is made from an elastomeric material such as silicone rubber and is positioned invalve chamber 20 closest toentrance orifice 14.Disk 36 has acentral aperture 38 defining a valve seat which is intended to seal against the introduced needle or filament upon insertion into access port 10, as will be described in more detail as follows. Stacked directly againstdisk 36 is sealingmember 40 which is preferably made, at least partially, of a hard material such as a metal. Sealingmember 40 as shown in Figures 1, 2 and 3 is a circular metal disk having three cuts intersecting at the center of the disk and extending radially to the outer perimeter but stopping short of the perimeter, thus defining three separate cantilever supported leaves 42. Each ofleaves 42 is locally deflected from the plane of the disk at the disk center to define asegment 43 which combine to define conical sealingplug 44.Plug 44 has an external generallyconical surface 46 with its center defining aconcave surface 48. Sealingmember 40 can be made from a flat sheet metal stock which is locally deflected at the center area to defineplug 44. Alternatively, the disk can be machined or cast such that theplug 44 is defined by a locally thickened region of the disk. -
Valve assembly 34 also incorporates an additionalleaflet valve element 52 formed from a flat sheet of elastomeric material.Valve element 52 defines radial cuts which join at the geometric center of the disk, defining separate valve leaves 54. - As shown in Figures 1 and 2, the three elements comprising
valve assembly 34 namely,valve disk 36, sealingmember 40 andleaflet valve 52 are stacked directly against one another and are trapped in position betweenaccess port housing 12 andoutlet plug 18. As shown in the Figures,housing 12 defines a relatively small diameter passageway on the side ofvalve assembly 34 closest toentrance passageway 16. In this manner,seal element 36 is constrained against deflecting towardentrance orifice 14 except at near its centralarea defining aperture 38. On the opposite side ofvalve assembly 34, outlet plug 18 defines a large diameter area for the deflection of the leaves ofvalve elements - The operation and cooperation of the elements defining access port 10 will now be described with particular reference to Figures 1 and 2. Figure 1 shows the configuration of
valve assembly 34 when access port 10 is in its normal condition, implanted within the patient and not being used for access. In that condition, the segments of sealingmember 40 making up sealingplug 44 project into and seal againstdisk aperture 38 which acts as a valve seat.Plug 44, having a conicaloutside surface 46, presses againstdisk aperture 38, causing it to be stretched and enlarged. Due to the contact betweendisk 36 and sealingmember 40, a seal against fluid leakage is provided. -
Leaflet valve element 52 is provided to enhance the level of sealing by preventing fluid leakage between sealing member leaves 42. In the normal condition of the device as shown in Figure 1, the valve leaves 54 meet to provide a fluid seal. As shown in Figure 3, as a means of providing enhanced fluid sealing, the orientation of the cuts defining leaflet valve leaves 54 and the cuts defining the individual sealing member leaves 42 are off-set or indexed so that they are not in registry. - Figure 2 shows the orientation of the elements of access port 10 upon insertion of accessing
external needle 58.Housing orifice 14 andpassageway 16 serve to direct and orientneedle 58 such that the sharp point of the needle strikesconcave surface 48 ofplug 44. Due to the enlargement ofvalve disk aperture 38 through its interaction withplug 44, the sharp point of the needle does not strikevalve disk 36. Asneedle 58 is forced through the device, sealing member leaves 42 are forced to deflect in the direction of theoutlet plug passageway 22. This movement ofleaves 42 causes thesegments defining plug 44 to move from engagement withdisk aperture 38 which is allowed to contract in diameter. The undeformed diameter ofaperture 38 is selected so that it will form a fluid seal against needle 58 (or another introduced filament such as a catheter around the needle which can be left in the device after the needle is removed). Continued deflection ofleaves 42 allows free passage of theneedle 58. Such deflections also causes valve leaves 54 to separate, allowing passage ofneedle 58 but without being damaged by contact with the needle point. - As is evident from the above description of the operation of access port 10, repeated
access using needle 58 will not damage the device since the needle repeatedly strikes the hardmaterial forming plug 44. Access port 10 also permits the introduction of other external filaments, such as an external catheter, optical fiber or guide wire, provided that it has sufficient rigidity to deflect the valve elements in the manner previously described. Access port 10 could also enable external filaments to be introduced vianeedle 58 either as fed through its center passageway, or introduced around the needle like a typical angiography catheter. - Figure 4 illustrates an
access port 60 incorporating avalve assembly 62 in accordance with the second embodiment of this invention. This embodiment, along with those described elsewhere in this specification have elements and features identical to those of the first embodiment, and are identified with like reference numbers. Figure 5 illustratesvalve assembly 62 which includes avalve disk 36 identical to that previously described. The distinction of this embodiment overvalve assembly 34 is that the sealingmember 64 which definesplug 70 is a composite structure. Sealingelement 64 is formed from an elastomeric orflexible base disk 66 having a number of radially projecting cuts defining individual leaves 68 as in the case of sealingmember 40 described previously. Attached to leaves 68 near the center ofbase disk 66 areplug segments 70 which together define a sealingplug 72 as in the prior embodiment which are made of a hard material such as a metal.Plug elements 70 are bonded or otherwise structurally affixed todisk 66. - In use,
valve assembly 62 operates in a manner consistent with the description ofvalve assembly 34. A principle advantage of the configuration ofvalve assembly 62 is that sealingelement disk 66 performs the combined functions of sealing as with theleaflet valve element 52 of the first embodiment, and further supports plugsegments 70. - Figures 6 and 7 illustrate an
access port 78 in accordance with a third embodiment of this invention.Access port 78 hasvalve assembly 80 with avalve disk 36 identical to that present in the first and second embodiments. In this embodiment, however, sealingmember 82 is a unitary structure which includesplug element 84 attached to a mountingring 86 via acantilever arm 88. As with the prior embodiments, plug 84 defines an externalconical surface 90 and a centralconcave surface 92. In this design, however, theplug 84 is a unitary element. - In operation,
valve assembly 80 operates as like those of the prior embodiments in that in a normal condition without an external filament inserted within the access device, plug 84 is in sealing engagement withdisk aperture 38. Upon the introduction of an external filament such asneedle 58, engagement between the needle and sealingplug 84 urges it out of engagement withdisk aperture 38, and deflects it sufficiently to allow passage of the needle, as shown in Figure 7. This process also results in the contraction of the diameter ofaperture 38, causing it to constrict around the introduced filament. A significant benefit ofvalve assembly 80 results from the fact thatplug 84 is a unitary structure and, therefore, does not provide a fluid leakage path. In the normal condition withplug 84 againstdisk aperture 38, a fluid seal is provided, and therefore, additional sealing elements such as aleaflet valve 52 shown in the first embodiment are unnecessary. - Figures 8 and 9 provide an illustration of
access port 102 in accordance with a fourth embodiment of this invention. This embodiment features a modifiedhousing 104 andoutlet plug 106.Housing 104 forms asmall diameter counterbore 108 extending towardentrance orifice 14.Piston element 110 is positioned withinhousing cavity 112 and includes acentral filament passageway 114.Piston 110 butts againstelastomeric bushing 116 havingpassageway 117, which is trapped withincounterbore 108. The head ofpiston 110 forms a dishedconcave surface 118 which supportsvalve ball 120.Piston surface 118 is formed to positionball 120 such that it is displaced from alignment withpiston passageway 114.Outlet plug 106 forms a generallyflat surface 122 withinhousing cavity 112 which provides for movement ofball 120, as is described in more detail below. - Operation of
access port 102 will be described with reference to Figures 8 and 9. Figure 8 represents the orientation of the elements comprising the device while insertingaccess needle 58. As is shown in Figure 8,access needle 58 engagesball 120 off-center. Continued insertion ofneedle 58 causesball 120 to be displaced upward to the position shown in Figure 9. During such displacement,piston 110 is caused to move towardentrance orifice 14 asball 120 "rides out" ofconcave surface 118. This displacement ofpiston 110 compresses bushing 116. Since bushing 116 is trapped withincounterbore 108 its axial compression causesbushing passageway 117 to constrict, thus causing it to seal against the introduced needle or other filament. As shown in Figure 9, onceball 120 is fully displaced, free passage to theexit passageway 124 is provided. Whenneedle 58 is completely removed from the device,ball 120 reseats in position withinconcave surface 118 which provides a fluid seal. It would be possible to enhance the fluid seal provided byball 120 in its normal position by providing an O-ring or other elastomeric valve seat (not shown) installed either onoutlet plug 106 or apiston 110 and engaging the ball. - While the above description constitutes the preferred embodiments of the present invention, it will be appreciated that the invention is susceptible of modification, variation and change without departing from the proper scope and fair meaning of the accompanying claims.
Claims (21)
- An implantable patient access port to permit the introduction of a needle for the removal or infusion of a fluid through an implanted catheter or permitting the introduction of a filament such as an external catheter, guide wire or optical fiber, comprising:
a housing defining a generally funnel shaped entrance orifice for guiding said needle into a housing entrance passageway, said housing further having an exit passageway with a valve chamber within said housing between said entrance and exit passageways, said housing further having means for connecting said exit passageway to said implanted catheter,
an elastomeric valve element positioned within said valve chamber and having an aperture positioned in alignment with said housing entrance passageway,
a plug which is normally biased into sealing engagement with said valve element aperture, at least a portion of said plug being formed of a hard material for repeated engagement with said needle, said plug positioned within said valve chamber such that upon insertion of said needle and engagement with said plug said plug is forced to deflect out of sealing engagement with said aperture, and
mounting means formed by said housing enabling fastening of said housing subcutaneously. - An implantable access port according to Claim 1 wherein said aperture is circular.
- An implantable access port according to Claim 1 wherein said plug is shaped to extend partially through and expand said valve element aperture when said needle or external filament is not within said housing and wherein said valve element aperture constricts into sealing engagement with said external filament upon said plug being forced from sealing engagement with said aperture.
- An implantable access port according to Claim 1 wherein said plug defines a convex outer surface which engages with said valve element apertures and aids in expanding said valve element aperture.
- An implantable access port according to Claim 1 wherein said housing passageway is oriented with respect to said plug whereby upon introduction of said needle or external filament, said needle or filament contacts said plug and is prevented from contacting said sealing element.
- An implantable access port according to Claim 1 wherein said plug defines a concave central area which is engaged by said needle or external filament.
- An implantable access port according to Claim 1 wherein said plug is at least partially formed of a metal material defining a hard surface which is contacted by said needle or external filament upon introduction of said needle or external filament and said hard surface resisting being damaged or gouged by said needle.
- An implantable patient access port according to Claim 1 wherein said sealing member comprises a disk having plural leaves which join at near the center of said disk to define said plug.
- An implantable access port according to Claim 8 wherein said plug is defined by a plug segment disposed at the center region of each of said leaves.
- An implantable access port according to Claim 8 wherein said sealing means disk is made of metal and wherein said plug segments are formed integrally by said disk.
- An implantable access port according to Claim 8 wherein said plug segments are formed by separate metal elements bonded to a substrate.
- An implantable access port according to Claim 1 wherein said plug is supported by an arm urging said plug into engagement with said valve element aperture.
- An implantable access device according to Claim 1 wherein said plug defines a convex shaped outer surface which engages said valve element aperture with a concave central region for engaging said needle or filament.
- An implantable access device according to Claim 1 further comprising a second elastomeric valve element disposed in engagement with said elastomeric valve element and positioned adjacent said exit passageway.
- An implantable access device according to Claim 14 wherein said second elastomeric valve element comprises a leaflet valve having plural leaves which join near the center of said valve.
- An implantable access port according to Claim 1 wherein said plug is in the form of a sealing ball element disposed within said valve chamber,
and wherein said valve element is disposed in said housing valve chamber defining a ball seat wherein when said ball element rests on said ball seat, fluid flow between said entrance and exit passageways is inhibited, said ball seat positioning said ball such that said needle or filament engages said ball and displaces said ball from sealing contact with said ball seat thereby allowing said needle or filament to enter said exit passageway, said ball being resiliently biased into engagement with said seat when said needle or filament is removed. - An implantable access device according to Claim 16 wherein said ball seat positions said ball off-center with respect to the longitudinal axes of said entrance and exit passageways.
- An implantable access device according to Claim 16 wherein said ball seat is defined by a piston member which is resiliently biased by an elastomeric biasing member.
- An implantable access device according to claim 18 wherein said piston member is caused to be displaced toward said entrance orifice upon said ball being displaced allowing passage of said external filament.
- An implantable access device according to Claim 19 wherein said elastomeric biasing member comprises a bushing having a central passageway through which said needle or external filament passes upon introduction of said needle or filament and wherein compression of said bushing caused by displacement of said ball element causes said central passageway to constrict into sealing engagement with said needle or filament.
- An implantable access device according to Claim 16 wherein said sealing ball element is formed of a hard material which is not gouged or damaged by engagement by said needle.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/818,626 US5226879A (en) | 1990-03-01 | 1992-01-10 | Implantable access device |
US818626 | 1992-01-10 |
Publications (2)
Publication Number | Publication Date |
---|---|
EP0551017A1 true EP0551017A1 (en) | 1993-07-14 |
EP0551017B1 EP0551017B1 (en) | 1998-03-25 |
Family
ID=25225992
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP92311887A Expired - Lifetime EP0551017B1 (en) | 1992-01-10 | 1992-12-31 | Implantable infusion device |
Country Status (7)
Country | Link |
---|---|
US (1) | US5226879A (en) |
EP (1) | EP0551017B1 (en) |
JP (1) | JPH06142210A (en) |
AU (1) | AU653662B2 (en) |
CA (1) | CA2086484A1 (en) |
DE (1) | DE69224892T2 (en) |
ES (1) | ES2113930T3 (en) |
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WO1983000367A1 (en) * | 1981-07-16 | 1983-02-03 | Trawöger, Werner | Valve used for the supply, the monitoring and taking of a medium contained in an implanted container |
DE3242870A1 (en) * | 1981-11-20 | 1983-06-01 | Machida Endoscope Co., Ltd., Tokyo | Arrangement for prevention of a return flow through the forceps insertion opening of an endoscope |
GB2192338A (en) * | 1986-07-07 | 1988-01-13 | Bristol Myers Co | Septum |
WO1991012838A1 (en) * | 1990-03-01 | 1991-09-05 | The Regents Of The University Of Michigan | Implantable infusion device |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
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WO1996040360A1 (en) * | 1995-06-07 | 1996-12-19 | Allegiance Corporation | Thoracentesis catheter instruments having self-sealing valves |
WO1997047248A1 (en) * | 1996-06-11 | 1997-12-18 | Origin Medsystems, Inc. | Reusable cannula with disposable seal |
US5820606A (en) * | 1996-06-11 | 1998-10-13 | Origin Medsystems, Inc. | Reusable cannula with disposable seal |
US6159182A (en) * | 1996-06-11 | 2000-12-12 | Applied Medical Resources Corporation | Reusable cannula with disposable seal |
WO1998030276A1 (en) * | 1997-01-07 | 1998-07-16 | Daig Corporation | Hemostasis valve |
US6142981A (en) * | 1997-01-07 | 2000-11-07 | Daig Corporation | Hemostasis valve |
EP0993839A1 (en) * | 1998-10-13 | 2000-04-19 | Terumo Kabushiki Kaisha | Self-retaining needle assembly and valve element for use therein |
US6221050B1 (en) | 1998-10-13 | 2001-04-24 | Terumo Kabushiki Kaisha | Self-retaining needle assembly and valve element for use therein |
Also Published As
Publication number | Publication date |
---|---|
EP0551017B1 (en) | 1998-03-25 |
AU3050492A (en) | 1993-07-15 |
JPH06142210A (en) | 1994-05-24 |
US5226879A (en) | 1993-07-13 |
DE69224892T2 (en) | 1998-09-17 |
DE69224892D1 (en) | 1998-04-30 |
AU653662B2 (en) | 1994-10-06 |
CA2086484A1 (en) | 1993-07-11 |
ES2113930T3 (en) | 1998-05-16 |
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